AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE 12000-000-0022

GUDID 27290109153111

Q-CORE MEDICAL LTD

Electric infusion pump administration set, single-use

• Primary Device ID: 27290109153111
• NIH Device Record Key: e6c0a59d-0397-4b99-ae50-0c335b9ea174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE
• Version Model Number: 12000-000-0022
• Catalog Number: 12000-000-0022
• Company DUNS: 533108028
• Company Name: Q-CORE MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com
• Phone: 949.288.5482
• Email: customerservice@eitanmedical.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109154623 [Primary]
GS1	27290109153111 [Package]; Contains: 17290109154623; Package: Cardboard box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192860

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-15

Devices Manufactured by Q-CORE MEDICAL LTD

• 07290109154213 - Sapphire Multi-Pump Mounting Device: 2022-11-14
• 17290109153985 - Infusion Pouch 500mL: 2022-11-14
• 17290109154043 - Homecare Large Backpack: 2022-11-14
• 17290109154050 - Communication Cable -US: 2022-11-14
• 27290109153937 - Multi-Pump Bracket Kit - US (4 units): 2022-11-14
• 27290109154071 - Multi-Pump Mounting System compatible with IPS- A: 2022-05-24
• 17290109153046 - AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE: 2022-05-23
• 27290109153067 - AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA: 2022-05-23